Two multi-center studies evaluating locally delivered doxycycline hyclate, placebo control, oral hygiene, and scaling and root planing in the treatment of periodontitis

Steven Garrett, Lonnie Johnson, Connie Hastings Drisko, Donald F. Adams, Carl Bandt, Bradley Beiswanger, Gary Bogle, Kevin Donly, William W. Hallmon, E. Brady Hancock, Philip Jerry Hanes, Charles E. Hawley, Robert Kiger, William Killoy, James T. Mellonig, Alan Polson, Frank J. Raab, Mark Ryder, Norman H. Stoller, Hom Lay WangLawrence E. Wolinsky, Gerald H. Evans, Charles Q. Harrold, Ralph M. Arnold, David F. Atack, Bryan Fitzgerald, Margaret Hill, Roger L. Isaacs, Hisham F. Nasi, Donald H. Newell, R. Lamont MacNeil, Simon MacNeill, Vladimir W. Spolsky, Susan P. Duke, Anne Polson, G. Lee Southard

Research output: Contribution to journalArticle

117 Citations (Scopus)

Abstract

Background: The clinical efficacy and safety of doxycycline hyclate (8.5% w/w) delivered subgingivally in a biodegradable polymer (DH) was compared to placebo control (VC), oral hygiene (OH), and scaling and root planing (SRP) in 2 multi-center studies. Method: Each study entered 411 patients who demonstrated moderate to severe periodontitis. Patients had 2 or more quadrants each with a minimum of 4 qualifying pockets ≥5 mm that bled on probing. At least 2 of the pockets were ≥7 mm. Treatment with DH, VC, OH, or SRP was provided at baseline and again at month 4. Clinical parameters were recorded monthly. Results: DH and SRP resulted in nearly identical clinical changes over time in both studies. Mean 9 month clinical attachment level gain (ALG) was 0.8 mm for the DH group and 0.7 mm for the SRP group in Study 1, and 0.8 mm (DH) and 0.9 mm (SRP) in Study 2. Mean probing depth (PD) reduction was 1.1 mm for the DH group and 0.9 mm for the SRP group in Study 1 and 1.3 mm for both groups in Study 2. Frequency distributions showed an ALG ≥2 mm in 29% of DH sites versus 27% of SRP sites in Study 1 and 31% of DH sites versus 34% of SRP sites in Study 2. PD reductions ≥2 mm were seen in 32% of DH sites versus 31% of SRP sites in Study 1 and 41% of DH sites versus 43% of SRP sites in Study 2. Comparisons between DH, VC, and OH treatment groups showed DH treatment to be statistically superior to VC and OH. Safety data demonstrated a benign safety profile with use of the DH product. Conclusions: Results of this trial demonstrate that treatment of periodontitis with subgingivally delivered doxycycline in a biodegradable polymer is equally effective as scaling and root planing and superior in effect to placebo control and oral hygiene in reducing the clinical signs of adult periodontitis over a 9-month period. This represents positive challenges resulting from the use of subgingivally applied doxycycline as scaling and root planing was not limited regarding time of the procedure or use of local anesthesia.

Original languageEnglish (US)
Pages (from-to)490-503
Number of pages14
JournalJournal of periodontology
Volume70
Issue number5
DOIs
StatePublished - Jan 1 1999

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Root Planing
Doxycycline
Oral Hygiene
Periodontitis
Placebos
Therapeutics
Safety
Polymers
Chronic Periodontitis
Placebo Effect
Local Anesthesia

Keywords

  • Doxycycline/therapeutic use
  • Drug delivery systems
  • Multi-center studies
  • Periodontitis/drug therapy

ASJC Scopus subject areas

  • Periodontics

Cite this

Two multi-center studies evaluating locally delivered doxycycline hyclate, placebo control, oral hygiene, and scaling and root planing in the treatment of periodontitis. / Garrett, Steven; Johnson, Lonnie; Drisko, Connie Hastings; Adams, Donald F.; Bandt, Carl; Beiswanger, Bradley; Bogle, Gary; Donly, Kevin; Hallmon, William W.; Hancock, E. Brady; Hanes, Philip Jerry; Hawley, Charles E.; Kiger, Robert; Killoy, William; Mellonig, James T.; Polson, Alan; Raab, Frank J.; Ryder, Mark; Stoller, Norman H.; Wang, Hom Lay; Wolinsky, Lawrence E.; Evans, Gerald H.; Harrold, Charles Q.; Arnold, Ralph M.; Atack, David F.; Fitzgerald, Bryan; Hill, Margaret; Isaacs, Roger L.; Nasi, Hisham F.; Newell, Donald H.; MacNeil, R. Lamont; MacNeill, Simon; Spolsky, Vladimir W.; Duke, Susan P.; Polson, Anne; Southard, G. Lee.

In: Journal of periodontology, Vol. 70, No. 5, 01.01.1999, p. 490-503.

Research output: Contribution to journalArticle

Garrett, S, Johnson, L, Drisko, CH, Adams, DF, Bandt, C, Beiswanger, B, Bogle, G, Donly, K, Hallmon, WW, Hancock, EB, Hanes, PJ, Hawley, CE, Kiger, R, Killoy, W, Mellonig, JT, Polson, A, Raab, FJ, Ryder, M, Stoller, NH, Wang, HL, Wolinsky, LE, Evans, GH, Harrold, CQ, Arnold, RM, Atack, DF, Fitzgerald, B, Hill, M, Isaacs, RL, Nasi, HF, Newell, DH, MacNeil, RL, MacNeill, S, Spolsky, VW, Duke, SP, Polson, A & Southard, GL 1999, 'Two multi-center studies evaluating locally delivered doxycycline hyclate, placebo control, oral hygiene, and scaling and root planing in the treatment of periodontitis', Journal of periodontology, vol. 70, no. 5, pp. 490-503. https://doi.org/10.1902/jop.1999.70.5.490
Garrett, Steven ; Johnson, Lonnie ; Drisko, Connie Hastings ; Adams, Donald F. ; Bandt, Carl ; Beiswanger, Bradley ; Bogle, Gary ; Donly, Kevin ; Hallmon, William W. ; Hancock, E. Brady ; Hanes, Philip Jerry ; Hawley, Charles E. ; Kiger, Robert ; Killoy, William ; Mellonig, James T. ; Polson, Alan ; Raab, Frank J. ; Ryder, Mark ; Stoller, Norman H. ; Wang, Hom Lay ; Wolinsky, Lawrence E. ; Evans, Gerald H. ; Harrold, Charles Q. ; Arnold, Ralph M. ; Atack, David F. ; Fitzgerald, Bryan ; Hill, Margaret ; Isaacs, Roger L. ; Nasi, Hisham F. ; Newell, Donald H. ; MacNeil, R. Lamont ; MacNeill, Simon ; Spolsky, Vladimir W. ; Duke, Susan P. ; Polson, Anne ; Southard, G. Lee. / Two multi-center studies evaluating locally delivered doxycycline hyclate, placebo control, oral hygiene, and scaling and root planing in the treatment of periodontitis. In: Journal of periodontology. 1999 ; Vol. 70, No. 5. pp. 490-503.
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abstract = "Background: The clinical efficacy and safety of doxycycline hyclate (8.5{\%} w/w) delivered subgingivally in a biodegradable polymer (DH) was compared to placebo control (VC), oral hygiene (OH), and scaling and root planing (SRP) in 2 multi-center studies. Method: Each study entered 411 patients who demonstrated moderate to severe periodontitis. Patients had 2 or more quadrants each with a minimum of 4 qualifying pockets ≥5 mm that bled on probing. At least 2 of the pockets were ≥7 mm. Treatment with DH, VC, OH, or SRP was provided at baseline and again at month 4. Clinical parameters were recorded monthly. Results: DH and SRP resulted in nearly identical clinical changes over time in both studies. Mean 9 month clinical attachment level gain (ALG) was 0.8 mm for the DH group and 0.7 mm for the SRP group in Study 1, and 0.8 mm (DH) and 0.9 mm (SRP) in Study 2. Mean probing depth (PD) reduction was 1.1 mm for the DH group and 0.9 mm for the SRP group in Study 1 and 1.3 mm for both groups in Study 2. Frequency distributions showed an ALG ≥2 mm in 29{\%} of DH sites versus 27{\%} of SRP sites in Study 1 and 31{\%} of DH sites versus 34{\%} of SRP sites in Study 2. PD reductions ≥2 mm were seen in 32{\%} of DH sites versus 31{\%} of SRP sites in Study 1 and 41{\%} of DH sites versus 43{\%} of SRP sites in Study 2. Comparisons between DH, VC, and OH treatment groups showed DH treatment to be statistically superior to VC and OH. Safety data demonstrated a benign safety profile with use of the DH product. Conclusions: Results of this trial demonstrate that treatment of periodontitis with subgingivally delivered doxycycline in a biodegradable polymer is equally effective as scaling and root planing and superior in effect to placebo control and oral hygiene in reducing the clinical signs of adult periodontitis over a 9-month period. This represents positive challenges resulting from the use of subgingivally applied doxycycline as scaling and root planing was not limited regarding time of the procedure or use of local anesthesia.",
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author = "Steven Garrett and Lonnie Johnson and Drisko, {Connie Hastings} and Adams, {Donald F.} and Carl Bandt and Bradley Beiswanger and Gary Bogle and Kevin Donly and Hallmon, {William W.} and Hancock, {E. Brady} and Hanes, {Philip Jerry} and Hawley, {Charles E.} and Robert Kiger and William Killoy and Mellonig, {James T.} and Alan Polson and Raab, {Frank J.} and Mark Ryder and Stoller, {Norman H.} and Wang, {Hom Lay} and Wolinsky, {Lawrence E.} and Evans, {Gerald H.} and Harrold, {Charles Q.} and Arnold, {Ralph M.} and Atack, {David F.} and Bryan Fitzgerald and Margaret Hill and Isaacs, {Roger L.} and Nasi, {Hisham F.} and Newell, {Donald H.} and MacNeil, {R. Lamont} and Simon MacNeill and Spolsky, {Vladimir W.} and Duke, {Susan P.} and Anne Polson and Southard, {G. Lee}",
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T1 - Two multi-center studies evaluating locally delivered doxycycline hyclate, placebo control, oral hygiene, and scaling and root planing in the treatment of periodontitis

AU - Garrett, Steven

AU - Johnson, Lonnie

AU - Drisko, Connie Hastings

AU - Adams, Donald F.

AU - Bandt, Carl

AU - Beiswanger, Bradley

AU - Bogle, Gary

AU - Donly, Kevin

AU - Hallmon, William W.

AU - Hancock, E. Brady

AU - Hanes, Philip Jerry

AU - Hawley, Charles E.

AU - Kiger, Robert

AU - Killoy, William

AU - Mellonig, James T.

AU - Polson, Alan

AU - Raab, Frank J.

AU - Ryder, Mark

AU - Stoller, Norman H.

AU - Wang, Hom Lay

AU - Wolinsky, Lawrence E.

AU - Evans, Gerald H.

AU - Harrold, Charles Q.

AU - Arnold, Ralph M.

AU - Atack, David F.

AU - Fitzgerald, Bryan

AU - Hill, Margaret

AU - Isaacs, Roger L.

AU - Nasi, Hisham F.

AU - Newell, Donald H.

AU - MacNeil, R. Lamont

AU - MacNeill, Simon

AU - Spolsky, Vladimir W.

AU - Duke, Susan P.

AU - Polson, Anne

AU - Southard, G. Lee

PY - 1999/1/1

Y1 - 1999/1/1

N2 - Background: The clinical efficacy and safety of doxycycline hyclate (8.5% w/w) delivered subgingivally in a biodegradable polymer (DH) was compared to placebo control (VC), oral hygiene (OH), and scaling and root planing (SRP) in 2 multi-center studies. Method: Each study entered 411 patients who demonstrated moderate to severe periodontitis. Patients had 2 or more quadrants each with a minimum of 4 qualifying pockets ≥5 mm that bled on probing. At least 2 of the pockets were ≥7 mm. Treatment with DH, VC, OH, or SRP was provided at baseline and again at month 4. Clinical parameters were recorded monthly. Results: DH and SRP resulted in nearly identical clinical changes over time in both studies. Mean 9 month clinical attachment level gain (ALG) was 0.8 mm for the DH group and 0.7 mm for the SRP group in Study 1, and 0.8 mm (DH) and 0.9 mm (SRP) in Study 2. Mean probing depth (PD) reduction was 1.1 mm for the DH group and 0.9 mm for the SRP group in Study 1 and 1.3 mm for both groups in Study 2. Frequency distributions showed an ALG ≥2 mm in 29% of DH sites versus 27% of SRP sites in Study 1 and 31% of DH sites versus 34% of SRP sites in Study 2. PD reductions ≥2 mm were seen in 32% of DH sites versus 31% of SRP sites in Study 1 and 41% of DH sites versus 43% of SRP sites in Study 2. Comparisons between DH, VC, and OH treatment groups showed DH treatment to be statistically superior to VC and OH. Safety data demonstrated a benign safety profile with use of the DH product. Conclusions: Results of this trial demonstrate that treatment of periodontitis with subgingivally delivered doxycycline in a biodegradable polymer is equally effective as scaling and root planing and superior in effect to placebo control and oral hygiene in reducing the clinical signs of adult periodontitis over a 9-month period. This represents positive challenges resulting from the use of subgingivally applied doxycycline as scaling and root planing was not limited regarding time of the procedure or use of local anesthesia.

AB - Background: The clinical efficacy and safety of doxycycline hyclate (8.5% w/w) delivered subgingivally in a biodegradable polymer (DH) was compared to placebo control (VC), oral hygiene (OH), and scaling and root planing (SRP) in 2 multi-center studies. Method: Each study entered 411 patients who demonstrated moderate to severe periodontitis. Patients had 2 or more quadrants each with a minimum of 4 qualifying pockets ≥5 mm that bled on probing. At least 2 of the pockets were ≥7 mm. Treatment with DH, VC, OH, or SRP was provided at baseline and again at month 4. Clinical parameters were recorded monthly. Results: DH and SRP resulted in nearly identical clinical changes over time in both studies. Mean 9 month clinical attachment level gain (ALG) was 0.8 mm for the DH group and 0.7 mm for the SRP group in Study 1, and 0.8 mm (DH) and 0.9 mm (SRP) in Study 2. Mean probing depth (PD) reduction was 1.1 mm for the DH group and 0.9 mm for the SRP group in Study 1 and 1.3 mm for both groups in Study 2. Frequency distributions showed an ALG ≥2 mm in 29% of DH sites versus 27% of SRP sites in Study 1 and 31% of DH sites versus 34% of SRP sites in Study 2. PD reductions ≥2 mm were seen in 32% of DH sites versus 31% of SRP sites in Study 1 and 41% of DH sites versus 43% of SRP sites in Study 2. Comparisons between DH, VC, and OH treatment groups showed DH treatment to be statistically superior to VC and OH. Safety data demonstrated a benign safety profile with use of the DH product. Conclusions: Results of this trial demonstrate that treatment of periodontitis with subgingivally delivered doxycycline in a biodegradable polymer is equally effective as scaling and root planing and superior in effect to placebo control and oral hygiene in reducing the clinical signs of adult periodontitis over a 9-month period. This represents positive challenges resulting from the use of subgingivally applied doxycycline as scaling and root planing was not limited regarding time of the procedure or use of local anesthesia.

KW - Doxycycline/therapeutic use

KW - Drug delivery systems

KW - Multi-center studies

KW - Periodontitis/drug therapy

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